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`DR. REDDY’S LABS., INC. EX. 1022 PAGE 1
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`

`

`Thirty-Sixth
`Annual Meeting of the
`American Society of Clinical Oncology
`May 20-23, 2000
`New Orleans, Louisiana
`Pro gram/Proceedings
`
`93 31~
`8/02 3\242-1? \ HLB
`Copyright 2000 American Society of Clinical Oncology
`
`501141 , .
`
`DR. REDDY’S LABS., INC. EX. 1022 PAGE 2
`
`

`

`Editor: Michael C. Perry, MD
`Associate Editor: Clay M. Anderson, MD
`
`ASCO Education and Training Department:
`Director: Michele K. Dinkel
`Assistant Director: Laura K. Ulepic
`ASCO Publications:
`Managing Editor and Senior Director: Deborah Whippen
`Special Projects Coordinator: Nicole Johnson
`Editorial Assistant: Na than Grace
`
`The American Society of Clinical Oncology Program/Proceedings (ISBN 0-9664495-4-1) is
`published by the American Society of Clinical Oncology, Alexandria, VA 22314. The 2000
`issue is produced and printed by Lippincott Williams & Wilkins, 351 West Camden Street,
`Baltimore, MD 21201-2436.
`
`Editorial correspondence and production questions should be addressed to American
`Society of Clinical Oncology Program/Proceedings, American Society of Clinical Oncology
`Publications Department, 850 Boylston Street, Chestnut Hill, MA 02467. Telephone:
`(617)739-8909. Fax: (617)739-8541.Email:ascopubs@asco.org.
`
`Single issue rate, $50.00. For all areas outside the United States and possessions, there is
`an additional charge for surface delivery of $10.00. For airmail delivery, add $15.00.
`
`Prices are subject to change. Back volumes exist and are available at previous published
`prices. For further information, call (617)739-8909.
`
`Copyright© 2000, American Society of Clinical Oncology. All rights reserved. No part of
`this publication may be reproduced or transmitted in any form or by any means, electronic or
`mechanical, including photocopy, recording, or any information storage and retrieval system,
`without written permission by the Society.
`
`The American Society of Clinica~ Oncology assumes no responsibility for errors or
`omissions in this document. The reader is advised to check the appropriate medical literature
`and the product information currently provided by the manufacturer of each drug to be
`administered to verify the dosage, the method and duration of administration, or
`contraindications. It is the responsibility of the treating physician or other health care
`professional, relying on independent experience and knowledge of the patient, to determine
`drug, disease, and the best treatment for the patient.
`
`Abstract management and indexing provided by Medical Support Systems, Cambridge,
`MA. Composition services and print production provided by Lippincott Williams & Wilkins,
`Baltimore, MD, and Cadmus Professional Services, Linthicum, MD.
`
`Copyright 2000 American Society of Clinical Oncology.
`
`DR. REDDY’S LABS., INC. EX. 1022 PAGE 3
`
`

`

`Contents
`
`lV
`V
`vi
`Vll
`lX
`
`Program and Proceedings Information
`ASCO OnLine (www.asco.org) Information . ... .. . .. . . . . ... . .... . .... ... . ... . . . . ..... .
`ASCO Officers and Directors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Committee Rosters .. . . . .. .. ... ... .... . . ... . .. . . ... . ... . .. . .. . .. . . ... . ....... .
`Session Descriptions .. . ... . ....... . . ... . . .. . .. . .. .... . ... . . . ... ... . . .. .... . . . .
`Calendar of Events .. . .. . . ... . . . . . ... . . . ... : .... . ... ..... . . . .. . . . . ...... . . .. . .
`Highlight Sessions
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Opening Ceremony
`XIX
`xx
`Plenary Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`xx1
`Integrated Symposium . . . ... . ............ . .. . . ; . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`xx111
`Special Sessions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Annual Business Meeting
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`xxix
`xxx
`Award Recipients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`xxx1
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`2000 ASCO Merit Awards
`2000 ASCO Travel Awards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xxxm
`General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xxxiv
`ASCO Shuttle Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xxxviii
`Ernest N. Morial Convention Center Map . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`xl
`2000 ASCO Exhibitor List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`xli
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`2000 Annual Meeting Support
`xliii
`ASCO Meeting Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`xlvi
`2000 Abstracts
`Plenary Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Integrated Session
`. .. . ... ................. . ... . . . .. . ........... ... . .. ... .. .. .
`Adult Leukemia and Lymphoma ........ . .. .. .... . . . .. ... ... .. . ...... . ........ . .. .
`Bone Marrow Transplantation/Cytokines .. . .......... . .. .. .. .. . . .. . ... .. .. .. .. . .. .. .
`Breast Cancer
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Central Nervous System Tumors .. . . .. . . . . .. . .. . . .. . . . . ........... .. .. . . . . .. . .... .
`Clinical Pharmacology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Gastrointestinal Cancer . .... .. . ..... .. ......... . .. ............................ .
`Genitourinary Cancer .. ..... .. . , . .. . . ... .. . .. . ..... .. . . . ... . ..... . . . ......... .
`Gynecologic Cancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Head and Neck Cancer .. ..... . .... . ... .... .. . .. .... . .. .. . . . . .... . . . . ...... . .. .
`Health Services Research . ..... ........ ... ..... .... . .. ... . .. .. .... . ........ ... . .
`Immunobiology and Biologic Therapy ... . . .... ....... . . .. . .... .. . . .. .. . . ... . . . ... . . .
`Lung Cancer
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .
`Melanoma and Sarcoma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Pediatric Oncology
`. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Symptom Management . ..... . . . ... . ... ... ...... . . .. .. .... . .. . .. . . ........ . ... .
`Tumor Biology/Human Genetics . . ...... . ..... . . .... ........ .. . .................. .
`Indexes
`Disclosure Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
`Author Index . . . .. ..... .. . . ... . . . .................... . .. . .. .... . . . . .. .... .. .
`Subject Index .. .... ... . ... . ... ...... .. ... .. . ............................... .
`
`la
`2a
`4a
`47a
`70a
`158a
`175a
`238a
`326a
`378a
`411a
`433a
`453a
`482a
`550a
`580a
`598a
`645a
`
`669a
`696a
`750a
`
`DR. REDDY’S LABS., INC. EX. 1022 PAGE 4
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`

`

`30a
`
`Adult Leukemia/ Lymphoma
`
`109
`True Thymic Hyperplasia (TIH) After Treatment of Adult Patients (Ptsl with
`Non-Hodfkin's Lymphoma (NHL) and Hod1kin's Disease (HD). C. Chacon, N.
`Tartas, E. Domenichini, H. Pascuccelli, V. Sporn, J. Mazzucco, J. Konn, L.
`Barazzutti, H. Ferro, P. Bussa, C. Foncuberta, G. Kusminsky, R. Chacon, J.
`Sanchez Avalos; Alexander Fleming Institute, Buenos Aires, Argentina;
`CEH, Buenos Aires, Argentina
`Although thymic enlargement has been occasionally reported after chen:io(cid:173)
`therapy (CHT) in young adults with HD and NHL, systematic st_ud1es
`including pathologic sampling of thymic RM have not been previously
`performed. We report here our experience in 8 pts treated for lymphoma
`who had thymic enlargement within twelve months_ of front line CHT. Six
`pts with HD and 2 pts with large cell lymphoma with sclerosis (DLC w/s)
`showed thymic enlargement on a computed tomography scan (CT) 2 to 12
`months after therapy. Seven pts showed the typical sail image in the
`anterior superior mediastinal space, while 1 pt showed a cystic mass. These
`were all adult pts, with a median age of 25 yrs old (15-38). All pts were
`asymptomatic and in complete remission at the time of the study. It is
`relevant to say that only 3 pts had initially bulky disease. In addition to the
`CT scans, 67Ga SPECT and MRI were perfomed in the 8 pts. The enlarged
`thymus was 67Ga negative in all 8 pts. The MRI was inconclusive in 1, false
`positive in 3 and negative for lymphoma in the remainder. In 4 individuals a
`biopsy of the thymus was performed, 3/4 fulfilled the histologic criteria of
`true thymic hyperplasia (TTH). In 1 pt, a muitilocular cystic thymus was
`excised. One patient with DLCL w/s had on the biopsy TIH plus hemor(cid:173)
`rhages and necrosis, interestingly this patient did not have bulky disease at
`presentation. The 8 pts are alive and in complete remission (CR) with a
`median follow up of 27 months (11-60). None of the pts developed other
`symptoms or signs of immune phenomena. TIH refers to an actual increase
`in thymic size, histologically has the appearance of normal thymus and
`should only have a minor component of ad ipose tissue, it is usually
`diagnosed with conventional radiologic studies. The results of CT scans,
`67Ga, MR I and histologic studies in this cohort of pts with TIH, were
`matched with clinical follow up. Contrarily to other reports a hyperplastic
`t hymus has always been 67Ga negative in our previous and present
`experience. MRI studies performed early after treatment might give false
`positive or inconclusive results. In conclusion we think that a residual mass
`in the superior anterior mediastinal space in a patient with lymphoma after
`treatment, might be due t o TIH. These pts must not be empirically
`irradiated if they have a negative gallium scan.
`
`111
`Encoura1in1 Improvement in Cytopenias of Patients with Myelodysplastic
`Syndromes (MOS} with Thalidomide. A. Raza, L. Lisak, C. Anderews, L.
`Little, F. Zorat, V. Shetty, S. A/vi, S. fliiriafe; K. A/lampallam, M. duRant,
`M. Ekbal, M. Muzammil; Rush Cancer Institute, Chicago, IL; Rush(cid:173)
`Presbyterian-St Luke's Medical Ctr, Chicago, II
`MOS patients present with variable cytopenias even though their bone
`marrows (8M) are generally hypercellular. Excessive cytokine-induced
`apoptosis of hematopoietic cells in the marrows has been proposed as a
`possible mechanism to explain the paucity of cells in the periphery. Tumor
`necrosis factor (TNF-a) is a pro-inflammatory cytokine which has been
`found in excessive amounts in MOS marrows. In addition, recent studies
`demonstrate excessive neo-angiogenesis in MOS marrows as well. TNF-a is
`a potent inducer of neo-angiogenesis via upregulation of vascular endothe(cid:173)
`lial growth factor (VEGF) and basic fibroblast growth factor (b-FGF). A
`strategy for improving ineffective hematopoiesis in MOS would be directed
`at suppressing TNF-a and neo-angiogenesis. Thal idomide is active at both
`levels. We have treated 61 MOS patients with 100-400 mg thalidomide po
`h.s. for 12 weeks. Of these, 22 had refractory anemia (RA), 13 had RA with
`ringed sideroblasts (RARS). 19 had RA with excess blasts (RAES}, 4 had
`RAES in transformation and 3 had CMMoL. Of 61 patients, 11 are off
`study, 25 are too early and 25 are evaluable for response, 17/25 are
`respondi ng while 8/25 are not. Three have a trilineage, 4 bil ineage and 10
`monolineage responses. Most dramatic improvements are noted in ery(cid:173)
`throid series in that long-term transfusion dependent patients are becom(cid:173)
`ing transfusion-independent. Responses can take up to 12 weeks to
`become apparent. Most patients tolerated the drug well in low doses (200
`mg hs). We conclude that thalidomide in low doses given for prolonged
`periods to MOS patient s can produce excellent palliation and deserves to
`be tested in a larger series of patients either alone or in combination with
`chemotherapy or anti-cytokine therapy.
`
`Proceedings of ASCO Volume 19 2000
`
`110
`Presence of Activation Markers of EBV and CMV in Myelod1splasia. S.
`Mundie, K. Allampa/lam, 8. Y. Mativi, 8. Dangerfield, J. Cartlidge, S. Afvi;
`c:-s7ietty, S. Dar, E. Broderick, P. Vengopal, s .. A. Gregory,, A. Raza; Rush
`Cancer Institute, Chicago, IL; Rush-Presbytenan-St Lukes Medical Ctr,
`Chicago, IL
`Herpes viruses have been known to establish latency in bone marrow (BM)
`early precursors such as a commo_n precursor o( d~ndrit!c a_nd myeloid
`cells. The present studies were designed to examine 1f act1vat1on of these
`latent viruses occurs in myelodysplastic syndromes (MOS) as compared to
`normal marrows. Two herpes viruses, viz. Cytomegalovirus (CMV), and
`Epstein Barr Virus (EBV), commonly found latent in BM cells ~ere
`investigated. First, BM aspirate mononuclea~ cells .(BMMNC) from nine(cid:173)
`teen MOS patients were studied in comparison_ with 7 normal healthy
`donors. One MOS patient was stud ied on 2 ~cas1ons. Per FAB _clas~1f1ca(cid:173)
`tion 8 MOS cases were refractory anem ia (RA), 1 RA with ringed
`side0roblasts (RARS), 3 RA with excess blasts (RAES), 1 RAES in transfor(cid:173)
`mation (RAEBt), 1 MOS ~AML, and 5 had chronic myelomonoceytic
`leukemia (CMMoL). The expression of 2 m-RNA transcripts; at least one of
`them being indicative of virus activation, were examined for both CMV and
`EBV, using a reverse transcriptase polymerase chain reaction (RT-PCR).
`The specific primers for the Major Immediate Early Protein (IEP) and DNA
`Polymerase I (DNA-Poll were selected for CMV, while for EBV, Latency
`related Membrane Protein 1 (LMP-1) and BZLF expression were assessed.
`All the MOS as well as the normal BM specimens showed the expression of
`latency related transcripts for the 2 viruses, I EP (Product-435bp) and
`LMP-1 (Product-106bp) respectively. In contrast, the expression of DNA(cid:173)
`Pol (356bp) indicative of active CMV infection was rare both in MOS (2/19)
`and Normal (ln} BMs. Interestingly, BZLF expression (608bp), indicative
`of active EBV, was evident in 10/ 19 MOS patients studied (>50%).
`Comparatively, only 2nnormal BMs showed BZLF(- 14%). Subsequently,
`long term stromal cultures were established from the BMs of MOS and
`normal individuals. At 75% confluency (-3-4weeks), they were overlay(cid:173)
`ered with cord blood MNC (CMNC) and after coincubation for one week
`RTPCR assays for EBV-BZLF and CMV-DNA Pol were performed on non 1
`adherent CMNC. Of the 3 CMNC specimens tested none showed these
`transcripts before overlayering, nor after coincubat ion with normal stroma.
`Interestingly 1/3 CMMNC sample showed EBV-BZLF and CMV-DNA Pol
`m-RNA, albeit with stromal cultures from different patients. Thus, MOS
`stroma may be capable of activating herpes viruses and hematopoietic cells
`may show active herpes virus. Further studies are warranted to assess the
`association of herpes viruses with the pathobiology of MOS.
`
`112
`Outcome of Patients with Multiple Myeloma (MM} Receivinf High-Dose
`Chemotherapy (HOC) and Hematopoietic Stem Cell Transplantation (HSCT}. Z.
`Nahleh, K. Zimmerman, I. Tabbara; George Washington Univ Sch of
`7ifea7cfne, BMT Program, Washington, DC
`Between 8/93 and 6/99, 14 patients with MM received HOC and HSCT.
`The P[ieparative regimen consisted of either high-dose melphalan (200
`mg/m I in 6 patients or cyclophospham ide (120 mg/kg) and busulfan (16
`mg/kg) in 8 patients. Half of the patients were male and the other half were
`females. The median ti me from diagnosis to transplant was 906 days
`(range 180-3600). The mean number of prior chemotherapy regimens was
`2 (range 1-4). Four patients (28.5%) had stage I, 2 patients (14.2%) had
`stage II and 8 patients (57 .1 %) had stage Ill. lgG monoclonal spike was
`present in 10 patients, lgA monoclonal spike in 1 patient and 3 patients
`had light chain disease. At the time of transplant, 2 patients (14.2%) had
`refractory disease to VAD chemotherapy, 8 patients (57 .1 %) had achieved
`a PR and 4 patients (28.5%) were in CR. Following HOC and HSCT, 12
`patients (85.7%) were in CR and 2 patients (14.2%) were in PR (1 patient
`had refractory disease and the other one was in PR.) The median
`progression-free survival (PFS) was 24.8 months (range 6-72 months.)
`Two patients died while in CR at 180 and 865 days post transplant from
`myocardial infarction and pneumonia respectively. Among patients who
`received Bu/Cy, the median time t o ANC> 500 was 11.5 days (9-18) and
`median time to platelet >20,000 was 14.4 days (7-38) as compared to 13
`days (5-28) and 13.5 days (5-30) respectively for patients who received
`high-dose melphalan. The three patients who developed major toxicities (1
`VOD and 2 hemorrhagic cystitis) received Bu/Cy. There was no treatment(cid:173)
`related mortality. These data suggest that HDC and HSCT in MM is well
`tolerated with minimal toxicity and is associated with long-term PFS. In
`addition, high-dose melphalan is associated with less toxicity than Bu/CY
`with comparable outcome.
`
`DR. REDDY’S LABS., INC. EX. 1022 PAGE 5
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